Breast Neoplasm FemaleNCT07465523
A Novel Approach in the Evaluation of Breast Masses With Doppler US
An observational study of Breast Neoplasm Female and Benign Breast Neoplasm, run by Ahmet Yesildag at 1 site in Turkey (Türkiye).
Trial summary
In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Benign Breast Neoplasm, Malign Breast Neoplasm
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2026to 19 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of female patients over the age of 18 who underwent breast biopsy in the radiology department due to a solid lesion in the breast.
Who may be able to join
- Those with solid breast masses
- Female patients
- Those with pathology results
Who cannot join
- Hypovascular masses
- Cystic breast masses
- Cases with mastitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karamanoğlu Mehmetbey University, KEAH
Karaman, Lütfen Seçiniz., 70200
Ahmet Yeşildağ, Prof.Dr, +905057728297, ahmetysd@hotmail.com
Gökçe Merve Yeşildağ, Dr, gmerveturgut@gmail.com
About this study
Official title: A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated.
Read the detailed description
The aim of this study is to reveal the role of differences in the resistive index of masses and surrounding tissue in distinguishing between benign and malignant masses using a new approach in the evaluation of breast masses with Doppler ultrasound. The minimum, maximum, and average RI values obtained from the mass and healthy breast tissue will be recorded. The relative RI value difference will be calculated from the RI values of the mass and healthy tissue. Based on the pathology results, the cases will be divided into two groups: benign and malignant. The threshold values of these values in malignant and benign masses will be determined and compared. Additionally, vascular index values in breast masses will be calculated and compared using the relatively new Doppler Microvascular Flow method.
- Conditions
- Breast Neoplasm Female, Benign Breast Neoplasm, Malign Breast Neoplasm, Doppler Ultrasound Diagnosis
- Keywords
- Breast Mass, Doppler Ultrasound, B-Mode Ultrasound, Resistive Index
What is being measured
The primary outcome is the main question the study is designed to answer.
A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
ROC curve analysis will be applied for the diagnostic performance of relative RI change in benign and malignant lesions.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start4 Mar 2026
- Primary completion5 May 2026 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmet Yesildag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Yesildag, Karamanoğlu Mehmetbey University
- Investigators
- Ahmet Yeşildağ, Prof.Dr., Study director, Karamanoğlu Mehmetbey UniverstyAhmet Yeşildağ, Prof.Dr., Study director, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465523
- Sponsor's protocol ID
- 26-2025/22
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Choi HY, Kim HY, Baek SY, Kang BC, Lee SW. Significance of resistive index in color Doppler ultrasonogram: differentiation between benign and malignant breast masses. Clin Imaging. 1999 Sep-Oct;23(5):284-8. doi: 10.1016/s0899-7071(99)00152-7.
PubMed 10665344Niu J, Ma J, Guan X, Zhao X, Li P, Zhang M. Correlation Between Doppler Ultrasound Blood Flow Parameters and Angiogenesis and Proliferation Activity in Breast Cancer. Med Sci Monit. 2019 Sep 19;25:7035-7041. doi: 10.12659/MSM.914395.
PubMed 31535669Mehta TS, Raza S, Baum JK. Use of Doppler ultrasound in the evaluation of breast carcinoma. Semin Ultrasound CT MR. 2000 Aug;21(4):297-307. doi: 10.1016/s0887-2171(00)90024-6.
PubMed 11014252
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
- ClinicalTrials.gov ID
- NCT07465523
- Acronym / sponsor ID
- 26-2025/22
- Conditions
- Breast Neoplasm Female, Benign Breast Neoplasm, Malign Breast Neoplasm, Doppler Ultrasound Diagnosis
- Keywords
- Breast Mass, Doppler Ultrasound, B-Mode Ultrasound, Resistive Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ahmet YesildagUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated.
Detailed description
The aim of this study is to reveal the role of differences in the resistive index of masses and surrounding tissue in distinguishing between benign and malignant masses using a new approach in the evaluation of breast masses with Doppler ultrasound. The minimum, maximum, and average RI values obtained from the mass and healthy breast tissue will be recorded. The relative RI value difference will be calculated from the RI values of the mass and healthy tissue. Based on the pathology results, the cases will be divided into two groups: benign and malignant. The threshold values of these values in malignant and benign masses will be determined and compared. Additionally, vascular index values in breast masses will be calculated and compared using the relatively new Doppler Microvascular Flow method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of female patients over the age of 18 who underwent breast biopsy in the radiology department due to a solid lesion in the breast.
Key inclusion criteria (3 listed)
- Those with solid breast masses
- Female patients
- Those with pathology results
Key exclusion criteria (3 listed)
- Hypovascular masses
- Cystic breast masses
- Cases with mastitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
Time frame: 3-4 months
ROC curve analysis will be applied for the diagnostic performance of relative RI change in benign and malignant lesions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 10665344Choi HY, Kim HY, Baek SY, Kang BC, Lee SW. Significance of resistive index in color Doppler ultrasonogram: differentiation between benign and malignant breast masses. Clin Imaging. 1999 Sep-Oct;23(5):284-8. doi: 10.1016/s0899-7071(99)00152-7.
- Background: PubMed 31535669Niu J, Ma J, Guan X, Zhao X, Li P, Zhang M. Correlation Between Doppler Ultrasound Blood Flow Parameters and Angiogenesis and Proliferation Activity in Breast Cancer. Med Sci Monit. 2019 Sep 19;25:7035-7041. doi: 10.12659/MSM.914395.
- Background: PubMed 11014252Mehta TS, Raza S, Baum JK. Use of Doppler ultrasound in the evaluation of breast carcinoma. Semin Ultrasound CT MR. 2000 Aug;21(4):297-307. doi: 10.1016/s0887-2171(00)90024-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Yeşildağ, Prof.Dr. study director
Karamanoğlu Mehmetbey Universty
Ahmet Yeşildağ, Prof.Dr. study director
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female and Benign Breast Neoplasm, run by Ahmet Yesildag at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Yeşildağ, Prof.Dr (+905057728297, ahmetysd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.